UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049697 |
|---|---|
| Receipt number | R000056607 |
| Scientific Title | Investigation of deodorizing effects of sofpyrronium bromide gel agent |
| Date of disclosure of the study information | 2022/12/05 |
| Last modified on | 2025/06/07 15:51:59 |
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Basic information
Public title
Investigation of deodorizing effects of sofpyrronium bromide gel agent in patients with axillary osmidorosis and axillary hyperhidrosis
Acronym
Investigation of deodorizing effects of sofpyrronium bromide gel agent
Scientific Title
Investigation of deodorizing effects of sofpyrronium bromide gel agent
Scientific Title:Acronym
Investigation of deodorizing effects of sofpyrronium bromide gel agent
Region
| Japan |
Condition
Condition
osmidrosis, hyperhidrosis
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In patients with axillary osmidrosis and axillary hyperhidrosis, we will investigate whether the sofpyrronium bromide gel has deodorizing
effects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage improvement in odor intensity assessment scores by study subjects
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The effect after 2 weeks in the drug application group will be examined.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 12 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Diagnosed with Stage IV or higher axillary osmidrosis by gauze test and axillary hyperhidrosis of Hyperhidrosis Disease Severity Scale (HDSS) 3 or higher.
2) Wanting to treat axillary odor.
Key exclusion criteria
1) Comorbid urination disorder due to enlarged prostate.
2) Comorbidity of angle-closure glaucoma.
3) Olfactory impairment.
4) There is a history of hypersensitivity to the components of this drug.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Hayashida |
Organization
Shimane University
Division name
Plastic and Reconstructive Surgery
Zip code
693-8501
Address
Enya cho 89-1, Izumo, Japan
TEL
0853232111
kenji@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Hayashida |
Organization
Shimane University
Division name
Plastic and Reconstructive Surgery
Zip code
693-8501
Address
Enya cho 89-1, Izumo, Japan
TEL
0853232111
Homepage URL
kenji@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shimane University Clinical Research Center
Address
Enya cho 89-1, Izumo, Japan
Tel
0853202515
kenkyu@med.shimane-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 05 | Day |
Last modified on
| 2025 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056607
